MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-38
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant products: - logic tibia ps mod insrt sz 4 13mm (cat# 02-012-35-4013 / serial# (b)(6)).H3: the revision reported was likely the result of wear of the tibial insert and patella over 9.25 years of implantation.Potential contributions from seating difficulties at the time of implantation and/or in-vivo forces leading to damage of the locking mushroom, subsequent movement of the tibial insert within the tibial tray, and ultimately backside wear of the polyethylene cannot be determined from the information provided and the devices were not available for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As reported, approximately 9.5 years post initial right tka, the 65 y/o male patient had poly visibly worn on x-rays.Patient has swollen and painful knee.Poly was identified as non-conform during the recall process and revision was scheduled to change poly.The poly was showing significant signs of wear on the articulating surface and the posterior face of the peg.The liner had thinned very significantly on the medial side, about 4/5 mm compared to its original thickness.Patella has signs of wear too, with evidence of osteolysis behind the poly.There were lot of fibrous tissues inside the joint which was removed.This was consistent to what can be found when significant poly wear takes place.Patient's tibial tray was kept.New poly was inserted (15mm), patella was removed and new patella was cemented (same size, 38mm).There was no breakage of device and no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays received.The devices are not available for evaluation due to the devices were kept by the hospital.No further information.This is 1 of 2 reports for this event.See mdr#1038671-2023-00578.

• Brand Name: OPTETRAK
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 21895937
• Report Number: 1038671-2025-01882
• Device Sequence Number: 3530495
• Product Code: JWH
• UDI-Device Identifier: 10885862039613
• UDI-Public: 10885862039613
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2018
• Device Catalogue Number: 200-02-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/23/2025
• Date Device Manufactured: 06/05/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male